A Phase 3b, Multicenter, Double-Blind, Fixed-Dose, Parallel-Group, Three Week Placebo Controlled Trial Evaluating the Safety and Efficacy of Asenapine in Subjects With Bipolar 1 Disorder Experiencing an Acute Manic or Mixed Episode (Protocol P05691 [Formerly 041044])
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 367
- 主要终点
- Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score at Day 21
研究概览
简要总结
This trial will study the efficacy and safety of a fixed dose of asenapine in participants diagnosed with Bipolar 1 Disorder. Participants who qualify for the study will be randomly assigned to receive a fixed dose of asenapine (either 5 mg or 10 mg twice daily [BID]) or placebo (BID) for 3 weeks. Throughout the trial, observations will be made on each participant at various times to assess the safety and effectiveness of the study treatment. The primary hypothesis is that there is at least one dose of asenapine that is superior to placebo in the change from baseline in manic symptoms (as measured by Young Mania Rating Scale [YMRS]) at Day 21 of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each participant must be at least 18 years of age
- •Male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception
- •Each participant must have a current diagnosis of Bipolar I Disorder, current episode manic or mixed
- •Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode
- •Each participant must have discontinued the use of all prohibited psychotropic medications
排除标准
- •A participant must not have a primary Axis I disorder other than Bipolar 1 Disorder (i.e., an Axis 1 disorder other than Bipolar 1 Disorder that is primarily responsible for current symptoms and functional impairment)
- •A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR™) criteria for substance abuse or dependence (excluding nicotine)
- •A participant must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (CSSRS).
研究组 & 干预措施
Asenapine 5 mg BID
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
干预措施: Asenapine (Drug)
Asenapine 10 mg BID
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
干预措施: Asenapine (Drug)
Placebo BID
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score at Day 21
时间窗: Baseline and Day 21
Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a mixed model repeated measures (MMRM) model. An improvement in symptoms is represented by change from baseline values that are negative.
次要结局
- Change From Baseline in Clinical Global Impression - Bipolar Mania - Severity of Illness (CGI-BP-S) Overall Score at Day 21(Baseline and Day 21)
- Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score(Baseline and Day 7 and Day 21)
- Percentage of Participants Who Are Y-MRS Responders at Day 21(Day 21)
- Change From Baseline in Y-MRS Total Score at Day 2, Day 4, Day 7 and Day 14(Baseline and Day 2, Day 4, Day 7 and Day 14)
- Percentage of Participants Who Are Y-MRS Responders at Day 2, Day 4, Day 7, Day 14(Day 2, Day 4, Day 7, Day 14)
- Percentage of Participants Who Are Y-MRS Remitters at Day 21(Day 21)
- Change From Baseline in CGI-BP-S Mania Score(Baseline and Day 2, Day 4, Day 7, Day 14, and Day 21)
- Change From Baseline in CGI-BP-S Depression Score(Baseline and Day 2, Day 4, Day 7, Day 14, and Day 21)
- Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Overall Bipolar Illness Score(Day 2, Day 4, Day 7, Day 14, and Day 21)
- Percentage of Participants Who Are Y-MRS Remitters at Day 2, Day 4, Day 7, Day 14, Day 21(Day 2, Day 4, Day 7, Day 14, Day 21)
- Change From Baseline in CGI-BP-S Overall Score at Day 2, Day 4, Day 7, Day 14(Baseline and Day 2, Day 4, Day 7, Day 14)
- Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Mania Score(Day 2, Day 4, Day 7, Day 14, and Day 21)
- Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Depression Score(Day 2, Day 4, Day 7, Day 14, and Day 21)
- Change From Baseline in Positive And Negative Syndrome Scale (PANSS) Total Score(Baseline and Day 7, Day 14, Day 21)
- Change From Baseline in PANSS Negative Subscale Score(Baseline and Day 7, Day 14, Day 21)
- Change From Baseline in PANSS Positive Subscale Score(Baseline and Day 7, Day 14, Day 21)
- Change From Baseline in PANSS General Psychopathology Subscale Score(Baseline and Day 7, Day 14, Day 21)
- Change From Baseline in PANSS Marder Factor Positive Symptom Score(Baseline and Day 7, Day 14, Day 21)
- Change From Baseline in PANSS Marder Factor Negative Symptom Score(Baseline and Day 7, Day 14, Day 21)
- Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score(Baseline and Day 7, Day 14, Day 21)
- Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score(Baseline and Day 7, Day 14, Day 21)
- Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score(Baseline and Day 7, Day14, Day 21)